Abstract: INFO18-SA
A Phase 2 Trial of Praliciguat Therapy in Patients with FSGS
Session Information
- Informational Posters - 3
October 24, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- No subcategory defined
Authors
- Borgi, Lea, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
- Tumlin, James A., Emory University School of Medicine, Atlanta, Georgia, United States
- Burke, Steven K., Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
- Gagne, Natalie, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
- Luo, Wenli, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
Description
Focal segmental glomerularsclerosis (FSGS) is a podocytopathy characterized by progressive glomerular scarring. In the kidneys, the nitric oxide (NO)–soluble guanylate cyclase (sGC)–cyclic guanosine 3’,5’-monophosphate (cGMP) pathway protects podocytes from injury and cell loss. Praliciguat is an investigational stimulator of sGC that has been evaluated in phase 1 and 2 clinical trials across cardiometabolic and renal indications. By stabilizing the nitrosyl-heme complex of native/reduced sGC, praliciguat amplifies endogenous NO-sGC-cGMP signaling to promote cell survival and has anti-inflammatory and antifibrotic effects. In preclinical trials, praliciguat in combination with enalapril improved kidney function.
This phase 2 multicenter trial (NCT07268638) is evaluating the safety and efficacy of praliciguat in adults with FSGS. Approximately 60 adult patients on the maximally tolerated dose of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker will be enrolled. Eligibility criteria are listed in the Table. Eligible patients will be randomized 1:1 to receive praliciguat once daily (QD) or matching placebo during a 24-week double-blind period, followed by a 24-week open-label extension of praliciguat QD. Study drug doses will be escalated to a target dose during the double-blind period. The primary efficacy endpoint is change in urine protein-to-creatinine ratio (UPCR) from baseline to week 24. The percentage of participants with partial remission (40% UPCR reduction and UPCR <1.5 g/g) at week 24 is a secondary endpoint.
The trial is currently ongoing and is open to enrollment. To be a participating investigator or referring physician, please email trials@akebia.com.
Eligibility Criteria—Praliciguat Phase 2 Trial in FSGS (NCT07268638)
| Inclusion Criteria | Exclusion Criteria |
| Adult patients (18 years and older) with a kidney biopsy collected within 5 years of screening consistent with FSGS OR kidney biopsy collected ≥5 years prior to screening consistent with FSGS plus the presence of a pathogenic gene mutation known to be associated with FSGS | Patients with collapsing FSGS or sickle cell disease |
| UPCR ≥1 g/g and eGFR ≥25 mL/min/1.73 m2 | HbA1c >8% |
| On the maximally tolerated dose of ACEi or ARB | Uncontrolled hypertension (≥160/100 mm Hg) |
ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; eGFR, estimated glomerular filtration rate; FSGS, focal segmental glomerularsclerosis; Hb, hemoglobin; UPCR, urine protein-to-creatinine ratio.
Funding
- Akebia Therapeutics, Inc.